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While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.

A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.

Novo Nordisk has plummeted back to Earth after a stunning rise driven by Ozempic and Wegovy. Can the storied Danish pharma recover?

Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.

Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.

After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.

As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.

Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision to declare the end of the shortage of Novo Nordisk’s semaglutide, Judge Mark Pittman agreed that Eli Lilly’s tirzepatide is in sufficient supply, meaning compounding pharmacies can no longer sell the lucrative weight loss drugs.

Novo Nordisk is intervening in the lawsuit filed by a drug compounders trade group against the FDA over the agency’s decision to declare the Wegovy shortage over. Eli Lilly did the same in a parallel case over Zepbound’s removal from the FDA shortage list and this week a judge denied the compounders’ injunction.